U.S. FDA advisory meetings through June 18

THIS DIARY IS FILED AS THE FOOD AND DRUG ADMINISTRATION UPDATES ITS SCHEDULE. ALL ITEMS ARE EDT/GMT.

For more information on the FDA's Advisory Committee meetings, see: here (Adds June 17 and 18 reproductive drugs meetings)

JOINT MEETING OF THE ANESTHETIC AND LIFE SUPPORT DRUGS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE

DATE: April 22, 0800/1200

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: Kalyani Bhatt, 301-827-7001

The committees will discuss a new drug application from Acura Pharmaceuticals (ACUR.O) for Acurox (oxycodone HCl and niacin) Tablets for the proposed indication of relief of moderate to severe pain where the use of an immediate-release, orally administered, opioid analgesic tablet is appropriate, and the results of studies evaluating the addition of niacin, added for the purpose of reducing the misuse of oxycodone. King Pharmaceuticals KG.N is jointly developing the drug.

ANTI-INFECTIVE DRUGS ADVISORY COMMITTEE

DATE: April 29, 0800/1200

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Minh Doan, 301-827-7001l

The committee will discuss the efficacy and safety of the World Health Organization's artesunate rectal suppositories for use as a single dose treatment for patients with acute malaria who cannot take medication by mouth and for whom injectable treatment is not available.

PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE

DATE: May 6, 0800/1200

LOCATION: The Inn and Conference Center, University of Maryland University College, Marriott Conference Centers, 3501 University Blvd. East, Adelphi, Md.

CONTACT: Diem-Kieu Ngo, 301-827-7001

The committee will discuss a supplemental new drug application from Questcor Pharmaceuticals (QCOR.O) for Acthar gel (repository corticotropin injection), proposed for the treatment of infantile spasms.

RISK COMMUNICATION ADVISORY COMMITTEE

DATE: May 6 and 7, 0800/1200

LOCATION: FDA, White Oak Campus, 10903 New Hampshire Ave., Silver Spring, Md.

CONTACT: Lee Zwanziger, 301-827-2895

The committee will review the state of current research in a range of fields relevant to improving risk communication at FDA, and discuss applications or gaps for strategic planning of risk communication at FDA.

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

DATE: May 7, 0800/1200

LOCATION: Hilton, 620 Perry Parkway, Gaithersburg, Md.

CONTACT: Christine Walsh or Denise Royster, 301-827-0314

In the morning, the committee will review and discuss available data regarding the unexpected finding of DNA originating from porcine circovirus type 1 (PCV 1) in Rotarix, a U.S. licensed vaccine manufactured by GlaxoSmithKline (GSK.L) and indicated for the prevention of rotavirus gastroenteritis in infants. The committee will discuss what additional steps should be considered to address this finding.

In the afternoon, the committee will discuss and make recommendations on the use of advanced analytical detection methods not currently applied for the characterization of cell substrates, viral seeds and other biological materials used in the production of viral vaccines for human use.

ARTHRITIS DRUGS ADVISORY COMMITTEE AND THE DRUG SAFETY AND RISK MANAGEMENT ADVISORY COMMITTEE

DATE: May 12, 0800/1200

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Anuja Patel, 301-827-7001

The committees will discuss NicOx SA's (NCOX.PA) new drug application for naproxcinod, a nonsteroidal anti-inflammatory drug (NSAID) product indicated for the treatment of the signs and symptoms of osteoarthritis.

ENDOCRINOLOGIC AND METABOLIC DRUGS ADVISORY COMMITTEE

DATE: May 27, 0800/1200

LOCATION: The Inn and Conference Center, University of Maryland University College, 3501 University Blvd. East, Adelphi, Md.

CONTACT: Paul Tran, 301-827-7001

The committee will discuss the safety and efficacy of Theratechnologies Inc's (TH.TO) Egrifta, or tesamorelin acetate, an experimental injectable treatment to help reduce excess abdominal fat in certain human immunodeficiency virus (HIV)-infected patients.

ANTIVIRAL DRUGS ADVISORY COMMITTEE

DATE: June 2, 0800/1200

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Paul Tran, 301-827-7001

The committee will discuss a biologics license application from AstraZeneca (AZN.L) unit MedImmune for motavizumab proposing an indication for the prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in children at high risk of RSV disease.

PERIPHERAL AND CENTRAL NERVOUS SYSTEM DRUGS ADVISORY COMMITTEE

DATE: June 10, 0800/1200

LOCATION: Hilton, 8727 Colesville Road, Silver Spring, Md.

CONTACT: Diem-Kieu Ngo, 301-827-7001

The committee will discuss Novartis AG's (NOVN.VX) (NVS.N) proposed Gilenia capsules to treat relapsing forms of multiple sclerosis. The drug is also known by its generic name, fingolimod hydrochloride.

ADVISORY COMMITTEE FOR REPRODUCTIVE HEALTH DRUGS

Date: June 17 and 18, 0800/1200

Location: Hilton, 620 Perry Parkway, Gaithersburg, Md.

Contact: Kalyani Bhatt, 301-827-7001

On June 17, the committee will discuss Laboratoire HRA Pharma's new drug application for ulipristal acetate tablets, an emergency contraceptive.

On June 18, the committee will discuss Boehringer Ingelheim Pharmaceuticals Inc's new drug application for flibanserin 100 milligram tablets for the proposed indication of the treatment of hypoactive sexual desire disorder in premenopausal women.